Tetanus immune globulin (human) - Biologic Drug Details

Summary for tetanus immune globulin (human)

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for tetanus immune globulin (human)

Recent Clinical Trials for tetanus immune globulin (human)

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Grifols Therapeutics LLC	Phase 4
Grifols Therapeutics Inc.	Phase 4

See all tetanus immune globulin (human) clinical trials

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. General brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for tetanus immune globulin (human) Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for tetanus immune globulin (human) Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for tetanus immune globulin (human) Derived from Patent Text Search

No patents found based on company disclosures

Tetanus immune globulin (human) Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Tetanus Immune Globulin (Human)

Market Overview

The global market for human tetanus immunoglobulin (TIG) is poised for significant growth, driven by several key factors. As of 2023, the market was valued at USD 120 billion and is projected to reach USD 179.07 billion by 2031, growing at a compound annual growth rate (CAGR) of 3.9% from 2024 to 2031[1].

Drivers of Market Growth

Increasing Global Awareness of Preventative Healthcare

The rising global awareness of preventative healthcare practices is a major driver of the market. Tetanus, a potentially lethal bacterial infection, necessitates the use of immunoglobulin products as part of tetanus prophylaxis, thereby increasing demand for TIG[1].

Improvements in Healthcare Infrastructure and Spending

Developments in healthcare infrastructure and rising healthcare spending in both developed and developing nations are also propelling market expansion. These improvements enhance access to healthcare services, including immunoglobulin products[1].

Proactive Vaccination Programs and Government Initiatives

Proactive vaccination programs and government initiatives aimed at eliminating tetanus further drive market growth. These programs often mandate tetanus immunization, which increases the demand for TIG[1].

Advances in Biotechnology and Immunization Techniques

Advances in biotechnology and immunization techniques have made it easier to produce more effective immunoglobulin formulations. This has increased market acceptance of these products[1].

Legal Frameworks and Public Awareness

Strict legal frameworks requiring tetanus immunization in many countries and increased public awareness campaigns about preventing tetanus also play significant roles in market expansion[1].

Market Segmentation

Application

The market is segmented based on application, with the primary segments being adults and children. The adults segment is expected to expand significantly, retaining its position throughout the forecast period[4].

Product Type

The market is also segmented by product type, including injection and freeze-dried injection. The injection segment accounted for a noticeable share of the global market in 2023 and is projected to experience significant growth in the near future[4].

Geographical Regions

The market is analyzed across various geographical regions, including North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa. Each region has its own growth trajectory and market dynamics[1][4].

Competitive Landscape

The competitive landscape of the human tetanus immunoglobulin market is characterized by several key players. Companies such as Baxalta and Octapharma are focusing on strategy building and expanding their product portfolios to strengthen their market positions[4].

Porter’s Five Forces Analysis

The market analysis includes a Porter’s Five Forces analysis, which elucidates the forces of buyers' bargaining power, suppliers' bargaining power, the threat of new entrants, the threat of substitutes, and the degree of competition within the market. This analysis helps in understanding the competitive dynamics and the position of various market participants[1].

Financial Projections

Market Size and Growth

The global human tetanus immunoglobulin market is expected to grow from USD 120 billion in 2023 to USD 179.07 billion by 2031. This growth is driven by the increasing demand for preventative healthcare measures and advancements in biotechnology[1].

Revenue and Volume Share

The report provides detailed insights into the revenue and volume share of each segment and sub-segment. It indicates the regions and segments that are expected to witness the fastest growth and dominate the market[1][4].

Technological and Manufacturing Aspects

Manufacturing Process

TIG products like HyperTET are produced using sophisticated purification processes, such as caprylate/chromatography purification, ensuring high quality and safety standards. This process contributes to the efficacy and reliability of the product[5].

Product Efficacy

HyperTET, for example, provides rapid immune coverage and is indicated for prophylaxis against tetanus following injury. It contains high titers of tetanus antibodies and provides passive immunity for up to 21 days, with peak blood levels of IgG obtained approximately 2 days after intramuscular injection[5].

Regulatory and Legal Frameworks

Government Initiatives and Legal Mandates

Government programs and legal mandates requiring tetanus immunization in various countries are significant factors driving market growth. These initiatives ensure a consistent demand for TIG products[1].

Challenges and Opportunities

Challenges

Despite the growth potential, the market faces challenges such as high fixed costs of entry for new players, limitations in perceived substitutability between innovator biologics and follow-on biologics (FOBs), and the lack of structural features that limit the rapid diffusion of generic drugs[3].

Opportunities

The market presents opportunities for growth through increased public awareness campaigns, advancements in biotechnology, and expanding healthcare infrastructure. Additionally, the need for effective preventative measures against tetanus infections continues to drive innovation and market expansion[1].

Key Takeaways

• The global human tetanus immunoglobulin market is projected to grow significantly, driven by increasing global awareness of preventative healthcare and advancements in biotechnology.
• The market is segmented by application, product type, and geographical regions, with the adults segment and injection product type expected to see significant growth.
• Key players are focusing on strategy building and expanding their product portfolios.
• Government initiatives and legal mandates play a crucial role in driving market growth.
• The market faces challenges related to high entry costs and perceived substitutability but presents opportunities through public awareness and technological advancements.

FAQs

Q: What is the projected market size of the human tetanus immunoglobulin market by 2031?

A: The global human tetanus immunoglobulin market is expected to reach USD 179.07 billion by 2031[1].

Q: What are the primary drivers of the human tetanus immunoglobulin market?

A: The primary drivers include increasing global awareness of preventative healthcare, improvements in healthcare infrastructure, proactive vaccination programs, and advances in biotechnology[1].

Q: Which segment is expected to expand significantly in the human tetanus immunoglobulin market?

A: The adults segment is expected to expand significantly, retaining its position throughout the forecast period[4].

Q: What is the role of HyperTET in tetanus prophylaxis?

A: HyperTET provides rapid immune coverage and is indicated for prophylaxis against tetanus following injury, offering passive immunity for up to 21 days[5].

Q: What are the challenges faced by new entrants in the human tetanus immunoglobulin market?

A: New entrants face challenges such as high fixed costs of entry, limitations in perceived substitutability between innovator biologics and FOBs, and structural limitations in the distribution system[3].

Sources

1. Market Research Intellect: "Human Tetanus Immunoglobulin Market Size, Trends and Projections"
2. HyperTET: "Tetanus Immune Globulin (Human) - HyperTET"
3. Duke University: "The Effect on Federal Spending of Legislation Creating a Regulatory Pathway for Follow-on Biologic Drugs"
4. Cognitive Market Research: "Human Tetanus Immunoglobulin Market Report 2024 (Global Edition)"
5. HyperTET: "HyperTET® Postexposure Treatment for Tetanus"